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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203013
Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/06/2013
Event Type  Malfunction  
Manufacturer Narrative

One used blade was returned for evaluation. The blade was reviewed for the cause of shedding and it was observed that there was some minor burnishing on the inner tip at the radius transition. The condition is consistent with normal wear during use. A review of the device history records were performed which confirmed no inconsistencies. A complaint history review has not identified additional complaints for this lot number on file. Root cause was not determined for this reported event. (b)(4).

 
Event Description

During a shoulder arthroscopy procedure, it was reported that the doctor noticed metal shavings. The surgeon suctioned them out, but could not remove all of the shavings. Follow up information indicates the surgeon did not indicate that shavings were left in the patient but an observer stated that they observed the shedding. They noted further that the surgeon flushed the site in order to remove all the particulate. A backup device was available to complete the case. No patient injuries or complications were reported.

 
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Brand Name4.5MM INCISOR PLUS PLATINUM BLADE
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key4930510
MDR Text Key22553031
Report Number1219602-2015-00395
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue Number72203013
Device LOT Number50727932
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2013
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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